DE69508580T2 - PELLETS - Google Patents

PELLETS

Info

Publication number
DE69508580T2
DE69508580T2 DE69508580T DE69508580T DE69508580T2 DE 69508580 T2 DE69508580 T2 DE 69508580T2 DE 69508580 T DE69508580 T DE 69508580T DE 69508580 T DE69508580 T DE 69508580T DE 69508580 T2 DE69508580 T2 DE 69508580T2
Authority
DE
Germany
Prior art keywords
cores
pharmaceutical
preparation
coating
pellets
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Expired - Lifetime
Application number
DE69508580T
Other languages
German (de)
Other versions
DE69508580D1 (en
Inventor
Tomas Norling
Lone Norgaard Jorgensen
Jens Hansen
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Xellia Pharmaceuticals ApS
Original Assignee
Dumex Alpharma AS
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Dumex Alpharma AS filed Critical Dumex Alpharma AS
Application granted granted Critical
Publication of DE69508580D1 publication Critical patent/DE69508580D1/en
Publication of DE69508580T2 publication Critical patent/DE69508580T2/en
Anticipated expiration legal-status Critical
Expired - Lifetime legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/5005—Wall or coating material
    • A61K9/5021—Organic macromolecular compounds
    • A61K9/5036—Polysaccharides, e.g. gums, alginate; Cyclodextrin
    • A61K9/5042—Cellulose; Cellulose derivatives, e.g. phthalate or acetate succinate esters of hydroxypropyl methylcellulose
    • A61K9/5047—Cellulose ethers containing no ester groups, e.g. hydroxypropyl methylcellulose
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0002—Galenical forms characterised by the drug release technique; Application systems commanded by energy
    • A61K9/0007—Effervescent
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1611—Inorganic compounds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/167—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction with an outer layer or coating comprising drug; with chemically bound drugs or non-active substances on their surface
    • A61K9/1676—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction with an outer layer or coating comprising drug; with chemically bound drugs or non-active substances on their surface having a drug-free core with discrete complete coating layer containing drug
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2072—Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
    • A61K9/2077—Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets
    • A61K9/2081—Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets with microcapsules or coated microparticles according to A61K9/50
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/5005—Wall or coating material
    • A61K9/5015—Organic compounds, e.g. fats, sugars
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/5005—Wall or coating material
    • A61K9/5021—Organic macromolecular compounds
    • A61K9/5026—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0087—Galenical forms not covered by A61K9/02 - A61K9/7023
    • A61K9/0095—Drinks; Beverages; Syrups; Compositions for reconstitution thereof, e.g. powders or tablets to be dispersed in a glass of water; Veterinary drenches
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/5073—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals having two or more different coatings optionally including drug-containing subcoatings
    • A61K9/5078—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals having two or more different coatings optionally including drug-containing subcoatings with drug-free core

Landscapes

  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Chemical & Material Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Inorganic Chemistry (AREA)
  • Mechanical Treatment Of Semiconductor (AREA)
  • Crystals, And After-Treatments Of Crystals (AREA)
  • Medicinal Preparation (AREA)

Abstract

A novel drug delivery system, e.g. in the form of a solid dosage form or a liquid formulation based on a pharmaceutical multiple unit in the form of cores such as, e.g., coated cores. The pharmaceutical formulations are based on a novel principle allowing preparation of cores such as, e.g., cores in the form of pellets, i.e. substantially spheric particles which have such a mechanical strength (expressed in terms of friability) that the cores are sufficiently robust to substantially remain intact after having been subjected to coating by standard pharmaceutical procedures well known by a person skilled in the art such as, e.g., a coating process involving a fluidized bed process. A spray-drying process for the preparation of the pharmaceutical formulation is also described.
DE69508580T 1994-06-15 1995-06-14 PELLETS Expired - Lifetime DE69508580T2 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DK69594 1994-06-15
PCT/DK1995/000240 WO1995034291A1 (en) 1994-06-15 1995-06-14 Pellets

Publications (2)

Publication Number Publication Date
DE69508580D1 DE69508580D1 (en) 1999-04-29
DE69508580T2 true DE69508580T2 (en) 1999-09-23

Family

ID=8096481

Family Applications (1)

Application Number Title Priority Date Filing Date
DE69508580T Expired - Lifetime DE69508580T2 (en) 1994-06-15 1995-06-14 PELLETS

Country Status (13)

Country Link
EP (1) EP0765157B1 (en)
AT (1) ATE177944T1 (en)
AU (1) AU697456B2 (en)
CA (1) CA2192086C (en)
DE (1) DE69508580T2 (en)
DK (1) DK0765157T3 (en)
ES (1) ES2131318T3 (en)
FI (1) FI118675B (en)
GR (1) GR3030256T3 (en)
HK (1) HK1010335A1 (en)
NO (1) NO315544B1 (en)
NZ (1) NZ288185A (en)
WO (1) WO1995034291A1 (en)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE10221726A1 (en) * 2002-05-16 2003-11-27 Sachtleben Chemie Gmbh X-ray barytes (chemically-pure barium sulfate) is used as an additive or aid in the production of medicines, foods or cosmetics, especially as a replacement for lactose

Families Citing this family (19)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
BE1011045A3 (en) * 1997-03-14 1999-04-06 Ucb Sa Pharmaceutical composition for controlled release of active substances.
US6200604B1 (en) * 1998-03-27 2001-03-13 Cima Labs Inc. Sublingual buccal effervescent
US6350470B1 (en) 1998-04-29 2002-02-26 Cima Labs Inc. Effervescent drug delivery system for oral administration
US6974590B2 (en) 1998-03-27 2005-12-13 Cima Labs Inc. Sublingual buccal effervescent
CA2241342C (en) * 1998-06-15 2000-02-08 Bernard Charles Sherman Pharmaceutical tablets comprising an nsaid and a prostaglandin
GB9819272D0 (en) * 1998-09-03 1998-10-28 Andaris Ltd Microparticles
GB0003782D0 (en) * 2000-02-17 2000-04-05 Dumex Ltd As Process
AUPR272901A0 (en) * 2001-01-25 2001-02-22 Gainful Plan Limited Method of preparing biological materials and preparations produced using same
US20030068356A1 (en) 2001-07-10 2003-04-10 Pather S. Indiran Sequential drug delivery systems
ITMI20011632A1 (en) * 2001-07-27 2003-01-27 Sanofi Synthelabo SOLID COMPOSITION CONTAINING SPORE OF NON-PATHOGENIC BACTERIA OF THE GENERAL BACILLUS
US9107804B2 (en) 2002-12-10 2015-08-18 Nortec Development Associates, Inc. Method of preparing biologically active formulations
US7198653B2 (en) 2003-07-31 2007-04-03 Delavau Llc Calcium carbonate granulation
JP5244318B2 (en) 2003-12-31 2013-07-24 シーマ・ラブス、インコーポレイテッド Effervescent oral opiate dosage forms and methods of administration of opiates
WO2007016948A1 (en) 2005-08-10 2007-02-15 Add Advanced Drug Delivery Technologies Ltd. Oral preparation with controlled release
EP1834634A3 (en) * 2006-03-08 2007-10-03 Rentschler Pharma GmbH Pharmaceutical multiple-unit composition
US9138414B1 (en) 2006-09-15 2015-09-22 Delavau Llc Calcium supplement having enhanced absorption
WO2012013928A1 (en) * 2010-07-27 2012-02-02 Norgine Bv Compositions
CN103313703A (en) * 2010-12-27 2013-09-18 富田制药株式会社 Decay-type nuclear particle for pharmaceutical formulation
US10405568B2 (en) * 2012-11-19 2019-09-10 Tracy L. Lundberg Flowable food composition with water-holding and lubricating agents

Family Cites Families (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
FR2292747A2 (en) * 1973-09-14 1976-06-25 Gewerk Victor Chem Werke Finely-divided calcium carbonate pigment - which is spray dried to obtain high apparent density and fine particle size
US4096246A (en) * 1976-10-06 1978-06-20 A/S Apothekernes Laboratorium For Specialpraeparater Zinc bacitracin composition for use as a feed supplement and method for making the same
US4164572A (en) * 1976-10-06 1979-08-14 A/S Apothekernes Laboratorium For Specialpraeparater Zinc bacitracin composition for use as a feed supplement and method for making the same
JPS5823361B2 (en) * 1976-10-26 1983-05-14 クミアイ化学工業株式会社 Manufacturing method of granular pesticide
SE450087B (en) * 1985-10-11 1987-06-09 Haessle Ab GRAINS WITH CONTROLLED RELEASE OF PHARMACIFICALLY ACTIVE SUBSTANCES APPLIED SIGNED ON A COMPACT INSULABLE NUCLEAR MATERIAL
DE3900811A1 (en) * 1989-01-13 1990-07-19 Kali Chemie Pharma Gmbh NEW MEDICINE
DE69111287T2 (en) * 1990-04-18 1995-12-21 Asahi Chemical Ind Spherical nuclei, spherical granules and processes for their production.
JPH04283520A (en) * 1991-03-12 1992-10-08 Asahi Chem Ind Co Ltd Spherical nuclei and spherical granule

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE10221726A1 (en) * 2002-05-16 2003-11-27 Sachtleben Chemie Gmbh X-ray barytes (chemically-pure barium sulfate) is used as an additive or aid in the production of medicines, foods or cosmetics, especially as a replacement for lactose

Also Published As

Publication number Publication date
FI965003A0 (en) 1996-12-13
ATE177944T1 (en) 1999-04-15
CA2192086A1 (en) 1995-12-21
DK0765157T3 (en) 1999-10-25
EP0765157B1 (en) 1999-03-24
NO965381D0 (en) 1996-12-13
FI965003A (en) 1996-12-13
EP0765157A1 (en) 1997-04-02
AU697456B2 (en) 1998-10-08
AU2732795A (en) 1996-01-05
ES2131318T3 (en) 1999-07-16
FI118675B (en) 2008-02-15
WO1995034291A1 (en) 1995-12-21
CA2192086C (en) 2000-01-25
NO965381L (en) 1997-02-13
NO315544B1 (en) 2003-09-22
NZ288185A (en) 1998-02-26
HK1010335A1 (en) 1999-06-17
DE69508580D1 (en) 1999-04-29
GR3030256T3 (en) 1999-08-31

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Legal Events

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